In the course of image-guided navigation, a probe typically comprising one or more location sensors can be navigated along desired paths and/or to desired destinations within a body organ while its updated location is being superimposed on an image of that organ.
Image-guided navigation systems utilizing a probe comprising one or more location sensors are generally known in prior art.
U.S. Pat. No. 6,711,429 to Gilboa et al., which is incorporated herein by reference, describes a system and method for displaying at least one point-of-interest of a body during an intra-body medical procedure. The method is effected by (a) establishing a location of the body; (b) establishing a location of an imaging instrument being for imaging at least a portion of the body; (c) defining at least one projection plane being in relation to a projection plane of the imaging instrument; (d) acquiring at least one point-of-interest of the body; and (c) projecting said at least one point-of-interest on said at least one projection plane; such that, in the course of the procedure, the locations of the body and the imaging instrument are known, thereby the at least one point-of-interest is projectable on the at least one projection plane even in cases whereby a relative location of the body and the imaging instrument are changed.
U.S. Pat. No. 6,226,543 to Gilboa et al., which is incorporated herein by reference, describes a method of recording and displaying in the context of an image a location of at least one point-of-interest in a body during an intra-body medical procedure. The method is effected by (a) establishing a location of the body; (b) inserting at least one catheter into a portion of the body, the at least one catheter including a first location implement; (c) using an imaging instrument for imaging the portion of the body; (d) establishing a location of the imaging instrument; (e) advancing the at least one catheter to at least one point-of-interest in the portion of the body and via a locating implement recording a location of the at least one point-of-interest; and (f) displaying and highlighting the at least one point-of-interest in the context of an image of the portion of the body, the image being generated by the imaging instrument; such that, in the course of the procedure, the locations of the body, the at least one catheter and the imaging instrument are known, thereby the at least one point-of-interest is projectable and displayable in the context of the image, even in cases where a relative location of the body and the imaging instrument are changed.
U.S. Pat. No. 5,558,091 to Acker et al. which is incorporated herein by reference, describes a magnetic position and orientation determining system, with which a representation of a probe can be superposed on a separately acquired image of a subject to show the position and orientation of the probe with respect to the subject.
U.S. Pat. No. 6,233,476 to Strommer et al., which is incorporated herein by reference, describes a medical device comprising a housing, a magnetic detection probe for detecting a plurality of magnetic fields, a biometric unit and a controller, connected to the magnetic detection probe, the biometric unit and the storage unit, wherein the controller receives magnetic field detection information from the magnetic detection probe, and wherein the controller operates the biometric unit in association with the magnetic field detection information.
U.S. Pat. No. 6,593,884 to Gilboa et al., which is incorporated herein by reference, describes a system and method for tracking the position and orientation of a probe, such as a catheter. Three at least partly overlapping planar antennas are used to transmit electromagnetic radiation simultaneously, with the radiation transmitted by each antenna having its own spectrum. A receiver inside the probe includes sensors of the three components of the transmitted field, with sensors for at least two of the three components being pairs of sensors, such as coils, on opposite sides of a common reference point. In one variant of the receiver, the coils are collinear and are wound about cores that are mounted in pairs of diametrically opposed apertures in the housing of the probe. Each member of a pair of coils that sense the same component of the transmitted field is connected to a different input of a differential amplifier. The position and orientation of the receiver relative to the antennas are determined noniteratively.
US Patent Application 2007/0055128 A1 to Glossop, which is incorporated herein by reference, describes a method and system for performing an image-guided endoscopic medical procedure. The method is described as including registering image-space coordinates of a path of a medical instrument within the anatomy of a patient to patient-space coordinates of the path of the medical instrument within the anatomy of the patient. In some embodiments, the image space coordinates of the path of the medical instrument are described as predicted coordinates such as, for example, a calculated centerline through a conduit-like organ, or a calculated “most likely path” of the medical instrument within the anatomy of the patient. In other embodiments, the path of the medical instrument is described as being an actual path determined using intra-operative images of the patient's anatomy with the medical instrument inserted therein. The registered instrument is described as then being navigated to one or more items of interest for performance of the endoscopic medical procedure.
U.S. Pat. No. 5,553,611 to Budd et al., which is incorporated herein by reference, describes a method including the collection of measurements that are taken from a set of measurement electrodes to determine the position of a catheter in a heart chamber.
U.S. Pat. No. 6,994,094 to Schwartz, which is incorporated herein by reference, describes a method for performing a procedure at the fossa ovalis in the septal wall of the heart, which includes the steps of providing a sheath having a body wherein the body has a lumen extending therethrough and an open end at the distal end of the body. The body also has at least one electrode and a position sensor at the distal end of the body. The position sensor generates signals indicative of the location of the distal end of the body. The sheath is navigated to the septal wall using the position sensor, and the fossa ovalis in the septal wall is identified using the at least one electrode of the sheath.
U.S. Pat. No. 6,253,770 to Acker et al., which is incorporated herein by reference, describes a catheter with a lumen wherein the lumen is obstructed by a portion of the catheter. The catheter includes a position detector at the tip of the catheter.
US Patent Application 2005/0171508 to Gilboa, which is incorporated herein by reference, describes a method for guiding an apparatus to a location within the body. The method includes providing a sheath having a lumen and inserting along the lumen a position sensor such that said position sensor is located within, or adjacent to, a distal portion of the sheath. Position information generated using the position sensor is then employed during guiding of the distal portion of the sheath to the location within the body. Once the sheath is in place, the position sensor is withdrawn along the lumen to free the lumen for guiding an apparatus to the location within the body. The position sensor is described as preferably being part of a six-degrees-of-freedom position sensing system. A corresponding catheter system is described as typically including at least one, and preferably two, steering mechanisms. At least one of the steering mechanisms is described as being deployed in a separate center-support distally with respect to the position sensor.
US Patent Application 2006/0184016 to Glossop, which is incorporated herein by reference, describes methods and apparatus for navigating a medical instrument to a target in the lung. In one embodiment, the method includes inserting a bronchoscope into the lung, inserting a catheter into the lung through the working channel of the bronchoscope, inserting a tracked navigation instrument wire into the lung through the catheter, navigating the tracked navigation instrument through the lung to the target, advancing the catheter over the tracked navigation instrument to the target, removing the tracked navigation instrument from the catheter, and inserting a medical instrument into the catheter, thus bringing the medical instrument in proximity to the target.
The use of images generated by multiple sources may in many cases provide clinical value that is greater than the one provided by any of these images alone. While some image-guided medical procedures make use of a single source of imaging, others combine imaging generated by multiple sources of imaging.
U.S. Pat. No. 6,019,724 to Gronningsaeter et al., which is incorporated herein by reference, describes a method for ultrasound guidance during medical procedures, wherein the location of a surgical tool, therapeutic radiation field or a diagnostic energy field is related to the coordinate system of an intra-operative 2D and/or 3D ultrasound imaging system and, optionally, to pre-operative MR/CT/X-ray data.
U.S. Pat. No. 6,996,430 to Gilboa et al., which is incorporated herein by reference, describes a method of displaying cross-sectional images of a body so as to render the cross-sectional images more interpretable.
US Patent Application 2005/0033149 to Strommer et al., which is incorporated herein by reference, describes a method and system for registering a first image with a second image, the system including a first medical positioning system for detecting a first position and orientation of the body of a patient, a second medical positioning system for detecting a second position and orientation of the body, and a registering module coupled with a second imager and with the second medical positioning system, the first medical positioning system being associated with and coupled with a first imager, the first imager acquiring the first image from the body, the first imager producing the first image by associating the first image with the first position and orientation, the second medical positioning system being associated with and coupled with the second imager, the second imager acquiring the second image and associating the second image with the second position and orientation, the registering module registering the first image with the second image, according to the first position and orientation and the second position and orientation.
Typically, an early step in an image-guided procedure is the registration of images to the patient's body. After registration a probe comprising one or more location sensors can be navigated along desired paths and/or to desired destinations in the body organ while its updated location is being superimposed on the image.
The process of registration is aimed at bringing the image and the body organ into the same reference frame of coordinates. It is typically performed by correlating known marked points (also known as markers, or fiducials) in the image with the corresponding observable points in the actual body organ. The locations of the fiducials in the actual organ are typically recorded by physically arriving at them with a probe equipped with one or more location sensors.
Fiducials or markers that are generally known in prior art in the context of image-to-body registration are typically categorized as either ‘artificial’ or ‘natural.’ The latter are also known as ‘anatomical.’
An article entitled “Real-time Bronchoscope Tip Localization Enables Three-dimensional CT Image Guidance for Transbronchial Needle Aspiration in Swine” by Solomon et al. (CHEST, November 1998), which is incorporated herein by reference, describes a study to determine the feasibility of using real-time bronchoscope position technology coupled with previously acquired three-dimensional CT data to enhance transbronchial needle aspiration (TBNA). Eight swine were given percutaneously created target lesions for TBNA. A miniature position sensor was placed at the tip of a bronchoscope, and real-time position information during bronchoscopy was presented on a monitor simultaneously displaying previously acquired three-dimensional CT data. Ten to twenty metallic nipple markers, 1 mm wide, were secured on the animals' anterior chest wall for later image registration. The position sensor was touched to approximately four metallic nipple markers to register the animal's chest with the CT images. The authors conclude that real-time bronchoscope position technology coupled with previously acquired CT images may aid with TBNA of nonvisible extrabronchial lesions.
U.S. Pat. No. 5,636,255 to Ellis, which is incorporated herein by reference, describes a method and system for correlating accuracy of computer tomography (CT) image resolution. Small radio-opaque markers having a diameter less than one slice width of a CT scan are embedded in the object, such as a bony skeletal member, to be measured, and the object is then CT scanned so that the radio-opaque markers appear in at least two slices of the scan. The markers are also physically located by detecting them with a sensor, such as a positioning pointer. Also described is one form of marker comprising a tantalum sphere mounted in a ceramic, preferably alumina, pin.
U.S. Pat. No. 5,729,129 to Acker, which is incorporated herein by reference, describes a system for locating objects in space, such as medical instruments within the body of a patient, based upon transmission of magnetic fields from coils in a fixed frame of reference to sensors on the object or vice versa. The current supplied to the coils is described as being adjusted to assure that the sensors receive fields within a preselected range of magnitudes regardless of the location of the object in space. This is described as assuring that the sensor operates within its optimum range, and permits use of compact transmitters and sensors.
U.S. Pat. No. 5,873,822 to Ferre et al., which is incorporated herein by reference, describes a system for monitoring the position of a medical instrument with respect to a patient's body and for displaying at least one of a plurality of prerecorded images of said body responsive to the position of said medical instrument.
U.S. Pat. No. 5,902,239 to Buurman, which is incorporated herein by reference, describes an image guided surgery system including a position detection system which has a camera unit and which measures positions of markers on the patient and of a surgical instrument. The image guided surgery system also includes a transformation unit which automatically derives the mapping associated with imaging of the patient. The imaging is described as being performed, for example, by way of x-ray computed tomography or magnetic resonance imaging. The transformation unit is described as being arranged to match positions on the patient to positions in the image. To that end, the transformation unit is described as computing the minimum of a cost function.
Separately, the use of natural markers for registration purposes is described in an article entitled “3D CT-Guided Bronchoscopy with Real-Time Electromagnetic Position Sensor” by Solomon et al. (CHEST, December 2000), which is incorporated herein by reference. The article describes a study to compare two different image registration methods for accurately displaying the position of a flexible bronchoscope on a previously acquired three-dimensional CT scan during bronchoscopy. A miniature electromagnetic position sensor was placed at the tip of a flexible bronchoscope. Previously acquired three-dimensional CT scans were registered with the patient in the bronchoscopy suite. Registration method 1 used multiple skin fiducial markers. Registration method 2 used the inner surface of the trachea itself for registration. Method 1 was objectively assessed by measuring the error in distance between the real skin marker position and the computer display position. Methods 1 and 2 were assessed by the bronchoscopist correlating visual bronchoscopic anatomic location with the computer display position on the CT image. In accordance with method 2, a sensor at the scope tip was brought to the origin of the right upper lobe bronchus, then to the carina, and finally to the origin of the left upper lobe bronchus. At each of these anatomic points, the corresponding CT position was indicated to the computer. After these anatomic approximations, the sensor was dragged along the anterior and lateral walls of the trachea. The computer accepted approximately 30 of these wall points to form an approximation of the trachea position.
superDimension, Ltd. (Herzliya, Israel) has presented its superDimension/Bronchus system which uses the main bifurcations in the bronchial tree as natural anatomical landmarks for point-by-point image registration. Those bifurcations are marked in the CT data and later touched under endoscopic vision by a probe comprising an electromagnetic location sensor.
U.S. Pat. No. 6,782,287 to Grzeszczuk et al., which is incorporated herein by reference, describes a method and apparatus for tracking a medical instrument, as it is moved in an operating space to a patient target site in the space, by constructing a composite, 3-D rendition of at least a part of the operating space based on an algorithm that registers pre-operative 3-D diagnostic scans of the operating space with real-time, stereo x-ray or radiograph images of the operating space.
U.S. Pat. No. 6,892,090 to Verard et al., which is incorporated herein by reference, describes a surgical instrument navigation system that visually simulates a virtual volumetric scene of a body cavity of a patient from a point of view of a surgical instrument residing in the cavity of the patient. The surgical instrument navigation system includes: a surgical instrument; an imaging device which is operable to capture scan data representative of an internal region of interest within a given patient; a tracking subsystem that employs electromagnetic sensing to capture in real-time position data indicative of the position of the surgical instrument; a data processor which is operable to render a volumetric, perspective image of the internal region of interest from a point of view of the surgical instrument; and a display which is operable to display the volumetric perspective image of the patient.
An article entitled “Computed Tomographic Colography and Virtual Colonoscopy” by Ahlquist et al., (Gastrointestinal Endoscopy Clinics of North America, July 1997, pp 439-452), which is incorporated herein by reference, describes CT colography (CTC) as being a powerful new approach for imaging the colorectum, and a promising screening tool for the detection of colorectal neoplasia. From data generated by a helical CT scan, CTC uses virtual reality technology to produce highly discriminant two- and three-dimensional images that permit a thorough and minimally invasive evaluation of the entire colorectum. A dynamic CTC display technique from the endoluminal perspective, called “virtual colonoscopy,” simulates colonoscopy by “flying” through the three-dimensional colon image. CTC is described as offering potential advantages in diagnostic performance, safety, and patient acceptance over current screening approaches. The authors state that although early data suggest excellent colorectal polyp detection rates, this nascent technology will require rigorous clinical investigation and further refinements to assess adequately its place in the endoscopist's armamentarium.
U.S. Pat. No. 5,920,319 to Vining et al., which is incorporated herein by reference, describes a computer system and a computer-implemented method for interactively displaying a three-dimensional rendering of a structure having a lumen and for indicating regions of abnormal wall structure.
An article entitled “A Virtual Bronchoscopic Navigation System for Pulmonary Peripheral Lesions” by Asano et al. (CHEST, 2006, 130:559-556), which is incorporated herein by reference, describes a study in which ultrathin bronchoscopy was performed for pulmonary peripheral lesions using a system that displays virtual bronchoscopy (VB) images of the lesion simultaneously with actual images, and navigates the bronchoscope to the target bronchus.
Software packages enabling the construction from CT data, and the subsequent viewing, of virtual endoscopy are available from multiple vendors. Such packages include, among others, the OsiriX Advanced Open-Source PACS Workstation DICOM Viewer which is a freeware, the General Electric Navigator (GE Medical Systems, Milwaukee, Wis., USA), the Vital Images Voxel View (Vital Images, Fairfield, Conn., USA), and the Voyager software (Phillips Medical Systems, Andover, Mass., USA).
U.S. Pat. No. 6,016,439 to Acker, which is incorporated herein by reference, describes a method and apparatus for synthetic view point imaging, the apparatus including an instrument insertable into the body of a patient. Using tissue image information defining an image of the patient's body, and defining the position of the distal end of the instrument within the body, synthetic images of the patient's body are synthesized having a viewpoint with a defined spatial relationship to the distal end of the instrument based on the image information and the determined position of the instrument.
US Patent Application Publication 2007/0015997 to Higgins et al., which is incorporated herein by reference, describes a method for providing guidance to the physician during a live bronchoscopy or other endoscopic procedures. The 3D motion of the bronchoscope is estimated using a fast coarse tracking step followed by a fine registration step. The tracking is based on finding a set of corresponding feature points across a plurality of consecutive bronchoscopic video frames, then estimating the new pose of the bronchoscope. A preferred embodiment is described in which the pose estimation is based on linearization of a rotation matrix. By giving a set of corresponding points across the current bronchoscopic video image, and the CT-based virtual image as an input, the same method is described as also being used for manual registration. The fine registration step is preferably a gradient-based Gauss-Newton method that maximizes the correlation between the bronchoscopic video image and the CT-based virtual image. The continuous guidance is described as being provided by estimating the 3D motion of the bronchoscope in a loop. Since depth-map information is available, tracking is described as being done by solving a 3D-2D pose estimation problem.
US Patent Application Publication 2007/0293721 to Gilboa, which is incorporated herein by reference, describes systems and methods employing a small gauge steerable catheter including a locatable guide with a sheath, particularly as an enhancement to a bronchoscope. A typical procedure is described as follows: The location of a target in a reference coordinate system is detected or imported. The catheter is navigated to the target which tracking the distal tip of the guide in the reference coordinate system. Insertion of the catheter is typically via a working channel of a conventional bronchoscope. Once the tip of the catheter is positioned at the target, the guide is withdrawn, leaving the sheath secured in place. The sheath is then used as a guide channel to direct a medical tool to the target.
US Patent Application Publication 2007/0276180 to Greenburg et al., which is incorporated herein by reference, describes a clip or flexible handle extension which facilitate simultaneous retention and operation of a bronchoscope and associated bronchoscopic tools held in one hand to allow operation by a single practitioner. Also described is an adapter for the connection port of the working channel of a bronchoscope, which performs both sealing and tool-locking functions. Also described is a guide sheath arrangement with a reduced-flexibility proximal portion, to facilitate insertion of tools into the guide sheath.
US Patent Application Publication 2007/0225559 to Clerc et al., which is incorporated herein by reference, describes a visualization system including a small gauge vision catheter that is designed to be stand-alone or received within an instrument channel of a larger endoscope. The vision catheter has imaging means disposable within an imaging channel, a working channel, and an electromagnetic sensor element insertable into the working channel of the catheter to provide position tracking. The working channel of the catheter also provides access for therapeutic and diagnostic tools.
US Patent Application 2006/0076023 to Rapacki et al., which is incorporated herein by reference, describes a flow control device which includes a sealing component that can be positioned within a bronchial lumen. The sealing component can comprise two or more overlapping segments that are movable relative to one another such that the segments collectively form a seal that can expand and contract in size to fit within and seal bronchial lumens of various sizes.
U.S. Pat. No. 6,592,520 to Peszynski et al., which is incorporated herein by reference, describes an intravascular ultrasound imaging apparatus and method. The ultrasound system includes an intravascular catheter with an ultrasound transducer array, a transmit beamformer, a receive beamformer, and an image generator. The intravascular catheter has an elongated body made for insertion into a blood vessel and connected to a catheter handle. The catheter includes a catheter core located inside a steerable guide sheath, both having a proximal part and a distal part. The catheter includes an articulation region connected to a positioning device for positioning the transducer array to have a selected orientation relative to an examined tissue region.
An article entitled “Multimodality Bronchoscopic Diagnosis of Peripheral Lung Lesions: A Randomized Controlled Trial,” by Eberhardt et al. (American Journal of Respiratory and Critical Care Medicine Vol 176. pp. 36-41, 2007), which is incorporated herein by reference, describes a trial in which endobronchial ultrasound (EBUS) and electromagnetic navigation bronchoscopy (ENB), and a combination of these modalities, were used for bronchoscopic diagnosis of peripheral lung lesions. The authors conclude that the combined EBUS and ENB improves the diagnostic yield of flexible bronchoscopy in peripheral lung lesions without compromising safety.
An article entitled, “Electromagnetic Navigation during Flexible Bronchoscopy,” by Schwartz et al. (Respiration 2003; 70:516-522), which is incorporated herein by reference, describes a study to determine the practicality, accuracy and safety of real-time electromagnetic navigation, coupled with previously acquired 3D CT images, in locating artificially created peripheral lung lesions in a swine model. The authors conclude that real-time electromagnetic positioning technology coupled with previously acquired CT images is an accurate technology added to standard bronchoscopy to assist in reaching peripheral lung lesions and performing biopsies.
An article entitled “Electromagnetic Catheter Navigation During Bronchoscopy,” by Hautmann et al. (Chest. 2005; 128:382-387), which is incorporated herein by reference, describes a study to assess the usability, accuracy, and safety of electromagnetic navigation during flexible bronchoscopy in a clinical setting. The article describes the navigation as having been performed using an electromagnetic tracking system with a position sensor encapsulated in the tip of a flexible catheter that was pushed through the working channel of the bronchoscope. Real-time, multiplanar reconstruction of a previously acquired CT data set provided three-dimensional views for localization of the catheter. To match the position of the sensor with the CT scan, four anatomic landmarks were used for registration. The sensor position generated in the navigation system was controlled by fluoroscopy, and the corresponding error distances were measured. This was performed with all solitary pulmonary nodules and at two different peripheral locations of the right upper lobe (RUL).
The following patents and patent applications, which may be of interest, are incorporated herein by reference:
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The following companies manufacture location sensors and/or image-guided navigation systems that comprise magnetic technologies:                MediGuide Ltd. (Haifa, Israel);        Biosense Webster Inc. (Diamond Bar, Calif., USA);        Northern Digital Inc. (Waterloo, Canada);        BrainLAB AG (Kirchheim/Heimstetten, Germany);        Ascension Technology Corporation (Burlington, Vt., USA)        
The following companies manufacture location sensors and/or image-guided navigation systems that comprise electromagnetic technologies:                superDimension Ltd. (Herzliya, Israel);        Polhemus Navigation Sciences, Inc. (Burlington, Vt., USA);        Surgical Navigation Technologies, Inc. (Louisville, Colo., USA);        Medtronic Navigation (Louisville, Colo., USA);        Traxtal Technologies (Toronto, Canada);        
The following company manufactures location sensors and/or image-guided navigation systems that comprise radiation-sensing technologies:                NavoTek, Ltd., also known as VasTrack, Ltd., (Yokne'am, Israel)        
The following company manufactures magnetically-maneuverable medical tools:                Sterotaxis, Inc. of St. Louis. (MO, USA)        
Location sensors comprising a longitudinal coil and having an outer diameter of approximately 0.25 mm to 0.3 mm were presented by:                MediGuide, Ltd. (Haifa, Israel) at the Innovations in Cardiovascular Interventions meeting held in Tel Aviv, Israel on Dec. 3 and 4, 2006, and        Ascension Technologies, Inc., (Burlington, Vt., USA) at the Trans Catheter Therapeutics conference and exhibition held in Washington D.C., USA on Oct. 22-24, 2007        
Olympus America, Inc. manufactures an endo-bronchial ultrasound probe (EBUS)
Boston Scientific and Volcano manufacture intra-vascular ultrasound probes (IVUS)
TopSpin Medical (Lod, Israel) manufactures an intra-vascular MRI probe (IVMRI)
Vida Diagnostics (Iowa City, Iowa, USA) manufactures the Emphysema Profiler and the Pulmonary Workstation.
DeepBreeze, Ltd. (Or Akiva, Israel) manufactures a Vibration Response Imaging system.
All of the above-listed references are incorporated herein by reference.